Color coded header bore identification

ABSTRACT

An implantable pulse generator includes a device housing containing pulse generator circuitry and a header connected to the device housing. The header includes a core assembly defining first and second lead bore cavities sized for receiving terminal pins of leads, first and second labels, and an outer layer. The first label is printed onto a surface of the core assembly proximate the first lead bore cavity and includes a first color. The second label is printed onto the surface of the core assembly proximate the second lead bore cavity and includes a second color different from the first color. The outer layer is overmolded over the core assembly so as to encapsulate the first and second labels and to allow access to the first and second lead bore cavities.

CLAIM OF PRIORITY

This application is a continuation of U.S. application Ser. No.14/498,111, filed Sep. 26, 2014, which claims priority to ProvisionalApplication No. 61/883,478, filed Sep. 27, 2013, each of which is hereinincorporated by reference in its entirety.

TECHNICAL FIELD

The present invention relates to implantable medical devices. Morespecifically, the invention relates to headers for implantable medicaldevices.

BACKGROUND

Various physiological functions can be managed and/or monitored usingmedical devices. Many such medical devices are implantable in a humanbody, such as implantable cardioverter-defibrillators (ICDs) orpacemakers. Such devices typically include a housing enclosing thedevice and may or may not include one or more medical electrical leadsthat can transmit electrical signals to and/or from a sensor, electrode,or other electrical component at a distal end of the medical electricallead. For example, such devices have been used in association withcardiac rhythm management, which can include cardiac pacing, cardiacdefibrillation, and/or cardiac therapy, among other procedures.

In some such devices, an implantable medical device includes a housingwith a header having one or more lead bore cavities for receiving andconnecting to one or more medical electrical leads. In embodiments wherethe header has multiple lead bore cavities, each lead bore cavity can bedesignated for connection to a specific medical electrical lead. Theimplantable medical device can fail to function or function incorrectlyif a medical electrical lead is inserted in an incorrect lead borecavity of the header.

SUMMARY

Disclosed herein are various embodiments of implantable pulsegenerators.

In Example 1, an implantable pulse generator includes a device housingcontaining pulse generator circuitry and a header connected to thedevice housing. The header includes a core assembly defining first andsecond lead bore cavities sized for receiving terminal pins of leads, afirst label printed onto a surface of the core assembly proximate thefirst lead bore cavity, a second label printed onto the surface of thecore assembly proximate the second lead bore cavity, and an outer layerovermolded over the core assembly so as to encapsulate the first andsecond labels and to allow access to the first and second lead borecavities. The first label includes a first color and the second labelincludes a second color different from the first color.

In Example 2, the implantable pulse generator according to Example 1,wherein the core assembly comprises an engineered thermoplasticpolyurethane and the outer layer comprises an epoxy resin that bonds tothe core assembly so as to isolate the first and second labels from anexterior of the header.

In Example 3, the implantable pulse generator according to any ofExamples 1-2, and further including a lenticular lens positionedproximate the first label.

In Example 4, the implantable pulse generator according to any ofExamples 1-3, wherein the header further includes a magnifying lenspositioned proximate the first label so as to magnify the first label.

In Example 5, the implantable pulse generator according to any ofExamples 1-4, wherein the outer layer is transparent.

In Example 6, the implantable pulse generator according to any ofExamples 1-5, and further including a first lead having a first terminalpin and a third label comprising the first color and a second leadhaving a second terminal pin and a fourth label comprising the secondcolor. The first terminal pin is positioned in the first lead borecavity and the second terminal pin is positioned in the second lead borecavity.

In Example 7, the implantable pulse generator according to any ofExamples 1-6, wherein the first label includes radiopaque ink patternedto define a first indicia that is viewable via radiology imaging systemsand the second label includes radiopaque ink patterned to define asecond indicia that is viewable via radiology imaging systems and thatis different from the first indicia.

In Example 8, the implantable pulse generator according to any ofExamples 1-7, wherein the first label comprises ink patterned as a firstindicia that is viewable in the visible light spectrum and the secondlabel comprises ink patterned as a second indicia that is viewable inthe visible light spectrum and that is different from the first indicia.

In Example 9, the implantable pulse generator according to any ofExamples 1-8, wherein the first lead bore cavity is a defibrillationlead bore cavity configured for connecting to a defibrillation leadterminal pin, the second lead bore cavity is a pacing lead bore cavityconfigured for connecting to a pacing lead terminal pin, the corefurther defines a low-voltage lead bore cavity configured for connectingto a low-voltage lead terminal pin, the first label is a red-pigmentedlabel positioned proximate the defibrillation lead bore cavity, thesecond label is a white-pigmented label positioned proximate the pacinglead bore cavity, and further including a green-pigmented label printedonto the surface of the core assembly proximate the low-voltage leadbore cavity.

In Example 10, the implantable pulse generator according to Example 9,wherein the red-pigmented label comprises a red-pigmented portion and afirst white-pigmented portion and wherein the green-pigmented labelcomprises a green-pigmented portion and a second white pigmentedportion.

In Example 11, the implantable pulse generator according to any ofExamples 9-10, wherein the red-pigmented label includes nogreen-pigmented portion and wherein the green-pigmented label containsno red-pigmented portion.

In Example 12, the implantable pulse generator according to any ofExamples 1-11, wherein the first label includes a first machine-readableindicia and where the second label includes a second machine-readableindicia different from the first machine-readable indicia.

In Example 13, a method of labeling a header of an implantable pulsegenerator includes printing a first label of a first color onto asurface of a core assembly proximate a first lead bore cavity, printinga second label of a second color different from the first color onto thesurface proximate a second lead bore cavity, and overmolding an outerlayer over the core assembly so as to encapsulate the first and secondlabels and to allow access to the first and second lead bore cavities.

In Example 14, the method according to Example 13, wherein the firstlabel comprises a first colored pigment not identified in any of 21C.F.R. 73 (Listing of Color Additives Exempt From Certification), 21C.F.R. 74 (Listing of Color Additives Subject to Certification), and (21C.F.R. 82 Listing of Certified Provisionally Listed Colors andSpecifications), and the second label comprises a second colored pigmentnot identified in any of 21 C.F.R. 73 (Listing of Color Additives ExemptFrom Certification), 21 C.F.R. 74 (Listing of Color Additives Subject toCertification), and (21 C.F.R. 82 Listing of Certified ProvisionallyListed Colors and Specifications) and that is different from the firstcolored pigment.

In Example 15, the method according to any of Examples 13-14, andfurther including patterning a first set of indicia onto the first labeland a second set of indicia different from the first set of indicia ontothe second label.

In Example 16, an implantable pulse generator includes a device housingcontaining pulse generator circuitry and a header connected to thedevice housing. The header defines first and second lead bore cavitiessized for receiving terminal pins of leads. A first label is positionedon a first portion of the header proximate the first lead bore cavity,wherein the first label comprises a first colored pigment not identifiedin any of 21 C.F.R. 73 (Listing of Color Additives Exempt FromCertification), 21 C.F.R. 74 (Listing of Color Additives Subject toCertification), and (21 C.F.R. 82 Listing of Certified ProvisionallyListed Colors and Specifications). A second label is positioned on asecond portion of the header proximate the second lead bore cavity,wherein the second label comprises a second colored pigment notidentified in any of 21 C.F.R. 73 (Listing of Color Additives ExemptFrom Certification), 21 C.F.R. 74 (Listing of Color Additives Subject toCertification), and (21 C.F.R. 82 Listing of Certified ProvisionallyListed Colors and Specifications). An outer layer encapsulates the firstand second labels and allows access to the first and second lead borecavities.

In Example 17, the implantable pulse generator according to Example 16,wherein the first lead bore cavity is a defibrillation lead bore cavityconfigured for connecting to a defibrillation lead terminal pin, thesecond lead bore cavity is a pacing lead bore cavity configured forconnecting to a pacing lead terminal pin, the header further defines alow-voltage lead bore cavity configured for connecting to a low-voltagelead terminal pin, the first label is a red-pigmented label positionedproximate the defibrillation lead bore cavity, the second label is awhite-pigmented label positioned proximate the pacing lead bore cavity,and further comprising a green-pigmented label positioned on a thirdportion of the header proximate the low-voltage lead bore cavity.

In Example 18, the implantable pulse generator according to claim 17,wherein the red-pigmented label comprises a red-pigmented portion and afirst white-pigmented portion and wherein the green-pigmented labelcomprises a green-pigmented portion and a second white pigmentedportion.

In Example 19, the implantable pulse generator according to any ofclaims 17-18, wherein the red-pigmented label includes nogreen-pigmented portion and wherein the green-pigmented label containsno red-pigmented portion.

In Example 20, the implantable pulse generator according to any ofclaims 17-19, and further including a defibrillation lead, a pacinglead, and a low voltage lead. The defibrillation lead has adefibrillation lead terminal pin and a first lead label of a hue that issubstantially the same as that of the red-pigmented label, wherein thedefibrillation lead terminal pin is positioned in the defibrillationlead bore cavity. The pacing lead has a pacing lead terminal pin and asecond lead label of a hue that is substantially the same as that of thewhite-pigmented label, wherein the pacing lead terminal pin ispositioned in the pacing lead bore cavity. The low-voltage lead has alow-voltage lead terminal pin and a third lead label of a hue that issubstantially the same as that of the green-pigmented label, wherein thelow-voltage lead terminal pin is positioned in the low-voltage lead borecavity.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a cardiac rhythm management (CRM) systemaccording to one embodiment of the present invention.

FIG. 2 is a perspective view of one embodiment of a pulse generator foruse in the CRM system of FIG. 1.

FIG. 3 is a side view of a core assembly for use in the pulse generatorof FIG. 2.

FIG. 4A is a perspective view of one side of an alternative embodimentof the pulse generator of FIG. 2.

FIG. 4B is a perspective view of another side of the pulse generator ofFIG. 4A.

FIG. 5 is an enlarged view of a label used on a header of the pulsegenerator of FIG. 2.

FIG. 6 is an enlarged view of an alternative embodiment of the label ofFIG. 5.

FIG. 7 is an enlarged view of another alternative embodiment of thelabel of FIG. 5, covered by a lens.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION

FIG. 1 is a schematic view of a cardiac rhythm management (CRM) system10 according to one embodiment. As shown in FIG. 1, the CRM system 10includes a pulse generator 12 coupled to a plurality of leads 14, 15,and 16 deployed in a patient's heart 18. The pulse generator 12 includesa housing 20 and a header 22 mounted on the housing 20. As further shownin FIG. 1, the heart 18 includes a right atrium 24 and a right ventricle26 separated by a tricuspid valve 28. During normal operation of theheart 18, deoxygenated blood is fed into the right atrium 24 through thesuperior vena cava 30 and the inferior vena cava 32. As further shown,the heart 18 includes a left atrium 34, which receives oxygenated bloodfrom the lungs, and a left ventricle 36, which pumps the oxygenatedblood to the body.

The header 22 of the pulse generator 12 is an output terminal headerwith a core assembly 38 substantially encapsulated in a header body 40.The core assembly 38 defines lead bore cavities 42, 44, and 46 forreceiving proximal ends of the leads 16, 15, and 14, respectively.

In the embodiment illustrated in FIG. 1, the leads 14, 15 and 16 extendfrom the pulse generator 12 through the superior vena cava 30 and intothe right atrium 24. The leads 14, 15, and 16 are medical electricalleads that operate to convey electrical signals and stimuli between theheart 18 and the pulse generator 12. In the particular embodimentillustrated in FIG. 1, the CRM system 10 is a cardiac resynchronizationtherapy (CRT) system configured for bi-ventricular pacing. As shown, thelead 14 has a distal end secured within the right ventricle 26, the lead15 extends into a coronary vein 48 for stimulating the left ventricle36, and the lead 16 has its distal end secured within the right atrium24. In various embodiments, the CRM system 10 is a CRT system withdefibrillation/cardioversion capabilities (i.e., a CRT-D system). Insuch embodiments, the lead 14 can also be a defibrillation lead withsingle or dual high-voltage shocking coil electrodes disposed along itslength. In alternative embodiments, the lead 15 can be omitted. Infurther alternative embodiments, additional leads (not shown) can beincluded as appropriate for a given application.

Lead labels 50, 52, and 54 are positioned on leads 14, 15, and 16,respectively. The lead labels 50, 52, and 54 can include one or morecolors and/or one or more indicia providing an indication of one or morecharacteristics of the respective lead. Exemplary characteristics caninclude, without limitation, structural or functional lead features(e.g., defibrillation capabilities, multi-polar electrodeconfigurations, and the like) or implantation locations (e.g., rightventricle, left ventricle, right atrium, etc.). Suitable indicia caninclude one or more letters, numbers, shapes, images, and/ormachine-readable indicia such as bar codes, magnetic stripes or othermachine-readable indicia. For example, in one embodiment the label 50can be red-pigmented, the label 52 can be green-pigmented, and the label54 can be white-pigmented.

The pulse generator 12 can be implanted subcutaneously within animplantation location or pocket in the patient's chest or abdomen. Thepulse generator 12 can be any implantable medical device known in theart, or later developed, for delivering an electrical therapeuticstimulus to the patient. In various embodiments, the pulse generator 12can be a neurostimulation device, a pacemaker, a CRT device, animplantable cardiac defibrillator, and/or can include both pacing, CRTand/or defibrillation capabilities (e.g., a CRT-D device).

In some embodiments the CRM system 10 can be configured to stimulatecardiac tissue and/or sense certain physiological attributes of theheart. However, in discussing embodiments of the present disclosure,reference is made primarily to stimulating body tissues. Those ofordinary skill in the art will recognize that some or all of theconfigurations can also be used to receive electrical signals from thebody.

FIG. 2 is a perspective view of a portion of the pulse generator 12showing the header body 40 as transparent. In the illustratedembodiment, the core assembly 38 is encapsulated in the header 22, withthe header body 40 overmolded over the core assembly 38. The lead borecavities 42, 44, and 46 extend through portions of both the header body40 and the core assembly 38, and are thus defined by both the headerbody 40 and the core assembly 38.

A plurality of electrical leads 56 connect pulse generator circuitry(not shown) within the housing 20 to electrical contacts 58 on the coreassembly 38. Thus, the pulse generator 12 can transmit electricalsignals to and from leads (such as the leads 14, 15, and 16, shown inFIG. 1) connected to the electrical contacts 58 in the header 22. Theheader 22 can also include an antenna 60 electrically connected to thepulse generator circuitry in the housing 20 for allowing remotecommunication with the pulse generator 12. The electrical leads 56, theelectrical contacts 58, and the antenna 60 can all be overmolded andencapsulated by the header body 40.

In the illustrated embodiment, the core assembly 38 is a single coredefining each of the lead bore cavities 42, 44, and 46. In alternativeembodiments, the core assembly 38 can include multiple interconnectedcores, each defining a different one of the lead bore cavities 42, 44,and 46. In further embodiments, the header 22 can include components andbe configured differently, as suitable for a given application.

As shown in FIG. 2, the header 22 includes labels 62, 64, and 66 on thecore assembly 38 encapsulated by the header body 40. In the illustratedembodiment, the label 62 is positioned on a portion of the header 22proximate the lead bore cavity 42. The label 64 is positioned on aportion of the header 22 proximate the lead bore cavity 44. The label 66is positioned on a portion of the header 22 proximate the lead borecavity 46. The labels 62, 64, and 66 are encapsulated by the header body40.

The labels 62, 64, 66 can include one or more colors and/or one or moreindicia. Suitable indicia can include one or more letters, numbers,shapes, images, and/or machine-readable indicia such as bar codes,magnetic stripes or other machine-readable indicia. Such indicia canidentify and/or provide information relating to the lead bore cavities42, 44, and 46. For example, in the illustrated embodiment, the leadbore cavity 42 is configured to receive a pacing lead positioned withinthe right atrium. As such, the label 62 includes the indicia of “RA” toindicate right atrium. Similarly, the lead bore cavity 44 is configuredto receive a left ventricular stimulation lead, and thus the label 64includes the indicia “LV” to indicate left ventricle. In addition, thelead bore cavity 46 is configured to receive a lead positioned in theright ventricle, and as such, the label 66 includes the indicia “RV” toindicate right ventricle. Thus, including indicia on the labels 62, 64,and 66 can ensure visual indication to the physician that the correctleads 14, 15, and 16 (shown in FIG. 1) are inserted into the correctlead bore cavities 46, 44, and 42, respectively.

In the illustrated embodiment, the lead bore cavities 44 and 46 are bothmulti-polar, specifically, quad-polar lead bore cavities configured tooperatively receive respective quad-polar leads. In one embodiment, thelead bore cavity 44 is configured to operatively receive a terminalconnector conforming to the IS-4 standard for multi-polar low-voltageleads, while the lead bore cavity 46 is configured to operativelyreceive a terminal connector conforming to the DF4 standard forhigh-voltage multi-polar leads. Because of structural similaritiesbetween IS4 and DF4 standard lead terminal connectors, in someembodiments, the lead bore cavity 46 may also be capable of at leastpartially receiving and operatively coupling to an IS4 connector of alow-voltage lead. Including the indicia on the labels 64 and 66 canoperate to provide additional visual indication as to the type of leadbore cavity into which the respective lead is being inserted.

The labels 62, 64, and 66 can include colors in addition to or insteadof indicia. For example, the label 62 can be white-pigmented in additionto including the indicia of RA. The label 64 can be green-pigmented inaddition to including the indicia of LV. The label 66 can bered-pigmented in addition to including the indicia of RV. Alternatively,the labels 62, 64, and 66 can be white, green, and red-pigmented(respectively) without including any indicia. In further alternativeembodiments, the labels 62, 64, and 66 can include different colorsand/or indicia as suitable for the application.

In some embodiments, the labels 62, 64, and 66 can include multiplecolors. For example, the label 62 can be white with black indicia, thelabel 64 can be green with white indicia, and the label 66 can be redwith white indicia. In some embodiments, labels can include at leastsome dedicated colors. For example, in one embodiment the label 64 caninclude a green pigmented portion and no red pigmented portion, and thelabel 66 can include a red pigmented portion and no green pigmentedportion.

In embodiments where the labels 62, 64, and 66 include machine-readableindicia, the respective labels 62, 64, and 66 can each include uniquemachine-readable indicia that are different from each other, allowing amachine to distinguish between the labels 62, 64, and 66.

In embodiments where the labels 62, 64, and 66 are colored, the labels62, 64, and 66 can have the same or similar color to that of the labels54, 52, and 50 (shown in FIG. 1), respectively. In one embodiment, eachof the labels 62, 64, and 66 can have the same color in the same hue asthat on a respective one of the labels 54, 52, and 50. Color-coding therespective labels 62, 64 and 66 can act as a confirmation feature tohelp ensure that the correct leads 14, 15, and 16 (shown in FIG. 1) areinserted into the correct lead bore cavities 46, 44, and 42,respectively.

FIG. 3 is a side view of the core assembly 38 according to an exemplaryembodiment. In the illustrated embodiment, the labels 62, 64, and 66 aredisposed on an outer surface 68 of the core assembly 38, proximate therespective lead bore cavities 42, 44, and 46. In one embodiment, thelabels 62, 64, 66 are disposed on the outer surface 68 via a printingprocess. Printing the labels 62, 64, and 66 onto the core assembly 38can simplify the manufacturing process as opposed to using separatelyprinted labels and can allow the labels 62, 64, and 66 to beencapsulated when the header body 40 (shown in FIGS. 1 and 2) is moldedover the core assembly 38. In alternative embodiments, the labels 62,64, and 66 can be encapsulated via another layer instead of, or inaddition to, the header body 40.

In embodiments where the labels 62, 64, and 66 are encapsulated, thelabels 62, 64, and 66 can be substantially physically and fluidlyisolated from the external environment so as to limit or prevent patientcontact with ink on the labels 62, 64, and 66. Substantially orcompletely isolating the printed labels 62, 64, 66 from contact with thepatient allows a wide range of potential pigments to be suitable for usein pigmenting the labels 62, 64, and 66. In one embodiment, the labels62, 64, and/or 66 can use one or more pigments not identified in 21C.F.R. 73 (Listing of Color Additives Exempt From Certification), 21C.F.R. 74 (Listing of Color Additives Subject to Certification), and (21C.F.R. 82 Listing of Certified Provisionally Listed Colors andSpecifications). For example, the label 62 can include an ultravioletcurable white ink that includes titanium dioxide and the label 66 caninclude an ultraviolet curable red ink that includes quinacridonecompound.

In some embodiments, the labels 62, 64, and 66 can include bright orhigh-contrast pigments that are viewable in the visible light spectrum.This can help visually distinguish the labels 62, 64, and 66 from oneanother. In one embodiment, the labels 62, 64, and 66 can be printedusing fluorescent brightener. Use of fluorescent brightener can alterperception of an off-white portion of the labels 62, 64, and 66 toappear more white. Use of fluorescent brightener can also allow thelabels 62, 64, and 66 to stand out when exposed to a black light. Inanother embodiment, the labels 62, 64, and 66 can be printed using anink that stands out when exposed to a light source other than whitelight, such as ultraviolet light, infrared light, or a monochromaticlight within the visible spectrum. In a further alternative embodiment,the labels 62, 64, and 66 can be printed using reflective ink.

In one embodiment, the core assembly 38 can comprise an engineeredthermoplastic polyurethane material and the header body 40 can comprisean epoxy resin material that bonds to the core assembly 38 so as tosubstantially or wholly isolate the labels 62, 64, and 66 from theexterior of the header 22. In alternative embodiments, the core assembly38 and/or the header body 40 can be formed of one or more other materialsuitable for sealing the labels 62, 64, and 66 from the exterior of theheader 22.

FIGS. 4A and 4B are partial perspective views of opposite sides of apulse generator 70, which is an alternative embodiment of the pulsegenerator 12. The pulse generator 70 is similar to the pulse generator12 except the pulse generator 70 includes a header 72 with additionallead bore cavities 74 and 76, in addition to the lead bore cavities 42,44, and 46.

FIG. 4A shows a label 78 proximate the lead bore cavity 74. The label 78can be printed with a “+” shaped indicium and/or a blue pigment. A label80 is proximate the lead bore cavity 42. The label 80 can be printedwith indicia of “RA” and/or a white pigment. A label 82 is proximate thelead bore cavity 44. The label 82 can be printed with indicia of “LV”and/or a green pigment.

As shown in FIG. 4B, the header 72 further includes a label 84 proximatethe lead bore cavity 76. The label 84 can be printed with a “−” shapedindicium and/or a red pigment. A label 86 is proximate the lead borecavity 46. The label 86 can be printed with indicia of “RV” and/or awhite pigment. A label 88 is proximate the lead bore cavity 44. Thelabel 88 can be printed with indicia of “LV” and/or a green pigment. Inthe illustrated embodiment, the label 88 is identical to the label 82(shown in FIG. 4A), as both of the labels 82 and 88 are printedproximate, are printed onto opposite sides of, and identify the samelead bore cavity 44.

In various embodiments, respective labels can be configured to includemultiple sections, regions or features having different characteristics(e.g., different colors, brightness under fluoroscopy, etc.) so as tofurther enhance the visibility of desired indicia.

FIG. 5 is an enlarged view of the label 62 according to an exemplaryembodiment. In some embodiments, the label 62 can be printed so as todefine first and second portions 90 and 92. The first portion 90 isshaped as the indicia “RA”, and the second portion 92 is the portionsurrounding the indicia “RA”. In one embodiment, the first portion 90can be black and the second portion 92 can be white. In otherembodiments, the first and second portions 90 and 92 can have othercolors so long as such colors have suitable contrast. In one embodiment,the label 62 can be printed by first printing a white circle-shapedbackground and then printing the first portion 90 on top of thatbackground. In another embodiment, the label 62 can be printed by firstprinting a black circle-shaped background and then printing the secondportion on top of that background. In other embodiments, the label 62can be printed by printing the first and second portions separately ontoa different background or onto no background at all.

In some embodiments, the label 62 can be printed with a radiopaque inkwhich has one or more radiopaque constituents. This can allow theindicia defined by the first portion 90 to be viewable via radiologyimaging systems (such as x-ray systems). In one embodiment, the firstportion 90 can be printed using radiopaque constituents while the secondportion 92 is printed without radiopaque constituents. Thus, the indiciadefined by the first portion 90 can appear lightly colored in aradiology imaging system. In another embodiment, the first portion 90can be printed without radiopaque constituents while the second portion92 is printed with radiopaque constituents. Thus, the indicia defined bythe first portion 90 can appear darkly colored in a radiology imagingsystem, as having an absence of radiopaque constituents. One, more, orall of the labels 50, 52, 54, 62, 64, 66, 78, 80, 82, 84, 86, and 88 canbe printed using radiopaque ink allowing radiology imaging systems todistinguish between different labels. Use of radiopaque ink can allowfor labels to be identified and distinguished not only during theimplantation of a pulse generator (such as pulse generators 12 and 70),but also after the pulse generator has been implanted into a patient'sbody.

FIG. 6 is an enlarged view of a label 94, which is similar to the label62 except the label 94 is printed with a border 96. The border 96 canincrease contrast and help improve visibility of the label 94. Inembodiments where the second portion 92 has a light color, the border 96can be black or a dark color. In embodiments where the second portionhas a dark color, the border 96 can be white or a light color.

FIG. 7 is an enlarged view of a label 98 covered by a lens 100. Thelabel 98 can include one or more colors and/or one or more indicia (suchas the indicium 104). In one embodiment, the lens 100 includes a surface102 that is convex so as to magnify the label 98 and any indiciathereon. Using the lens 100 for magnification can allow the label 98 tobe printed relatively small while still being viewable.

In another embodiment, the lens 100 can be a lenticular lens with thesurface 102 including an array of magnifying lenses suitable formagnifying different images from different angles. The label 98 can beprinted with multiple images suitable for use with the lens 100 toproduce different appearances when viewed from different angles. Forexample, in one embodiment, the label 98 can appear from a first angleas a colored label (showing for example red, white, green, or blue)without showing or without clearly showing indicia (such as the indicium104). The label 98 can then appear from a second angle as a label havingthe indicium 104 (showing for example “RA”, “RV”, “LV”, “+”, or “−”). Inone embodiment, the lens 100 can be operably positioned proximate one ormore labels (such as the labels 50, 52, 54, 62, 64, 66, 78, 80, 82, 84,86, and 88). In alternative embodiments, one or more labels can eachhave its own lenticular lens.

Therefore, as described above, pulse generators (such as the pulsegenerators 12 and 70) can include one or more labels having color,indicia, or both that can help identify and distinguish different leadbore cavities. This can assist physicians in readily and efficientlyidentifying the different lead bore cavities for connecting tocorresponding leads. Printing labels onto a core and then overmoldingover the core can allow for efficient encapsulation of the labels andcan hermetically seal the labels from patient contact. Encapsulating thelabels can allow for use of a number of pigments that do not appear in21 C.F.R. 73 (Listing of Color Additives Exempt From Certification), 21C.F.R. 74 (Listing of Color Additives Subject to Certification), and (21C.F.R. 82 Listing of Certified Provisionally Listed Colors andSpecifications), which can allow for selection of colors that improvecontrast. Use of machine-readable indicia, ink having radiopaqueconstituents, magnifying and lenticular lenses, and/or specialized inksor brighteners can further improve a physician's ability to identify anddistinguish different lead bore cavities both during and afterimplantation of the pulse generators.

In a variation of each of the above described embodiments, the headerbody may be molded or otherwise formed as described above but withoutone or more of the labels being embedded within the material of theheader body. For each of the labels not embedded with the header body, arecess can be ground, drilled, or otherwise formed within the materialof the header body. Each recess can be dimensioned to receive the label.For example, the depth, length, and width (or radius), of the recess canbe larger than the thickness, length, and width (or radius) of the labelsuch that the label fits entirely within the recess and no part of thelabel protrudes out of the recess (e.g., beyond the outer surface of theheader body). The recess can then be filled in with material topartially or fully encapsulate the label within the recess. The materialcan fully cover the label within the recess. The label may be entirelysealed within the recess such that no part of the label is exposed on anexterior of the pulse generator and that no part of the label may comeinto contact with tissue or fluids of the patient. The recess may befilled in the same manner as any molding step referenced herein,including an over molding step. The recess may be filled with anadhesive material that is injected into the recess or poured into therecess. Suitable materials for filling the recess and encapsulating thelabel include epoxy, acrylic, polymer (silicone, urethane), and/or anyother material referenced herein.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

We claim:
 1. An implantable pulse generator system comprising: a headerconnected to a device housing, the header including: a core assemblydefining first and second lead bore cavities; a first label formed froma first ink having a first pigment printed onto and in contact with asurface of the core assembly proximate the first lead bore cavity,wherein the first label comprises a first color; a second label formedfrom a second ink having a second pigment, different from the firstpigment, printed onto and in contact with the surface of the coreassembly proximate the second lead bore cavity, wherein the second labelcomprises a second color different from the first color; and a firstlens in contact with and covering a portion of at least one of the firstlabel and the second label.
 2. The implantable pulse generator system ofclaim 1, further including: a first lead having a first terminal pin anda first lead label of a hue that is substantially the same as that ofthe first color; and a second lead having a second terminal pin and asecond lead label of a hue that is substantially the same as that of thesecond color.
 3. The implantable pulse generator system of claim 2,further including: a second lens positioned proximate to at least one ofthe first lead label and the second lead label.
 4. The implantable pulsegenerator system of claim 3, wherein the at least one of the first labeland the second label proximate to the first lens and the at least one ofthe first lead label and the second lead label proximate to the secondlens include multiple images such that different appearances areproduced when viewed through the first and second lens at differentangles.
 5. The implantable pulse generator system of claim 4, whereinthe first and second lens are lenticular lens.
 6. The implantable pulsegenerator system of claim 3, wherein the first label includes radiopaqueink patterned to define a first indicia and the second label includesradiopaque ink patterned to define a second indicia that is differentfrom the first indicia, wherein the first lead label includes radiopaqueink patterned to define a third indicia and the second lead labelincludes radiopaque ink patterned to define a fourth indicia differentfrom the third indicia, and wherein the first, second, third, and fourthindicia is viewable via radiology imaging systems.
 7. The implantablepulse generator system of claim 3, wherein the first label includesradiopaque ink patterned to define a first indicia and the second labelincludes radiopaque ink patterned to define a second indicia that isdifferent from the first indicia, wherein the first lead label includesradiopaque ink patterned to define a third indicia and the second leadlabel includes radiopaque ink patterned to define a fourth indiciadifferent from the third indicia, and wherein the first, second, third,and fourth indicia is viewable in the visible light spectrum.
 8. Theimplantable pulse generator system of claim 1, wherein the core assemblyincludes an engineered thermoplastic polyurethane.
 9. The implantablepulse generator system of claim 1, wherein the first label includes afirst machine-readable indicia, the second label includes a secondmachine-readable indicia different from the first machine-readableindicia, the first lead label includes a third machine-readable indicia,and the second lead label includes a fourth machine-readable indiciadifferent from the third machine-readable indicia.
 10. The implantablepulse generator system of claim 9, wherein the first machine-readableindicia corresponds to the third machine-readable indicia and the secondmachine-readable indicia corresponds to the fourth machine-readableindicia.
 11. The implantable pulse generator system of claim 1, furtherincludes: an outer layer overmolded over the core assembly so as toencapsulate the first and second labels from an external environment andto allow access to the first and second lead bore cavities.
 12. Theimplantable pulse generator system of claim 11, wherein the outer layeris transparent.
 13. The implantable pulse generator system of claim 12,further including: a device housing containing pulse generatorcircuitry.
 14. An implantable pulse generator system comprising: aheader connected to a device housing, the header including: a coreassembly defining first and second lead bore cavities; a first labelformed from a first ink having a first pigment printed onto and incontact with a surface of the core assembly proximate the first leadbore cavity, wherein the first label comprises a first color; and asecond label formed from a second ink having a second pigment, differentfrom the first pigment, printed onto and in contact with the surface ofthe core assembly proximate the second lead bore cavity, wherein thesecond label comprises a second color different from the first color; afirst lead having a first terminal pin and a first lead label of a huethat is substantially the same as that of the first color; a second leadhaving a second terminal pin and a second lead label of a hue that issubstantially the same as that of the second color; and a first lens incontact with and covering a portion of at least one of the first leadlabel and the second lead label.
 15. The implantable pulse generatorsystem of claim 14, further including: a second lens positionedproximate to at least one of the first label and the second label. 16.The implantable pulse generator system of claim 15, wherein the at leastone of the first label and the second label proximate to the first lensand the at least one of the first lead label and the second lead labelproximate to the second lens include multiple images such that differentappearances are produced when viewed through the first and second lensat different angles.
 17. The implantable pulse generator system of claim15, wherein the first and second lens are lenticular lens.
 18. Theimplantable pulse generator system of claim 14, further including: adevice housing containing pulse generator circuitry; an outer layerovermolded over the core assembly so as to encapsulate the first andsecond labels from an external environment and to allow access to thefirst and second lead bore cavities.
 19. A method of labeling a headerof an implantable pulse generator, the method comprising: printing afirst label and a second label onto a surface of a core assembly, thefirst label proximate a first lead bore cavity and the second labelproximate a second lead bore cavity; printing a third label on a firstlead configured to be received within the first lead bore cavity;printing a fourth label on a second lead configured to be receivedwithin the second lead bore cavity; positioning a first lens in contactwith and covering a portion of at least one of the first label and thesecond label; positioning a second lens in contact with and covering aportion of at least one of the third label and the fourth label.
 20. Themethod of claim 19, further including: patterning a first set of indiciaonto the first label and a second set of indicia different from thefirst set of indicia onto the second label; and patterning a third setof indicia onto the third label and a fourth set of indicia differentfrom the third set of indicia onto the fourth label.